FDA: 50 medical devices at risk of shortages after Hurricane Maria

The Food and Drug Administration is monitoring dozens of medical devices produced in Puerto Rico for potential shortage risks, according to FDA Commissioner Scott Gottlieb, MD.

Puerto Rico houses more than 50 medical device manufacturing plants that produce more than 1,000 different devices, ranging from surgical instruments to cardiac pacemakers. Devicemakers face numerous manufacturing challenges on the island — including a lack of power, connectivity and necessary raw materials — that have hindered their ability to reach normal production levels since Hurricane Maria made landfall last month.

The agency is monitoring 50 devices made on the island that are either considered life-sustaining or are only produced by a single manufacturer.

"The FDA is working closely with about 10 manufacturers — some of which are the sole manufacturer of a certain device type — to prevent medical device product shortages across the U.S.," Dr. Gottlieb said Thursday. "We are particularly focused on blood-related medical devices."

The agency is also working to mitigate potential shortages by importing devices from outside the country or allowing companies to switch manufacturing to different production sites, according to Dr. Gottlieb.

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